NCT01935934

Cabozantinib S-Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer

A Phase 2 Study of XL184 (Cabozantinib) in Recurrent or Metastatic Endometrial Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well cabozantinib s-malate works in treating patients with endometrial cancer that has come back (recurrent) or has spread to other places in the body (metastatic). Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Determine efficacy of single agent cabozantinib s-malate (cabozantinib) in women previously receiving one line of chemotherapy for metastatic endometrial cancer or with progression within 12 months of completing adjuvant therapy, with co-primary endpoints of objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and progression-free-survival at 12 weeks (PFS). SECONDARY OBJECTIVES: I. Correlation of clinical response with baseline molecular status of archival tumor (hepatocyte growth factor receptor \[c-met\] amplification \& mutation status) and overall survival. OUTLINE: Patients receive cabozantinib s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks or every 6 months.

Conditions

• Endometrial Adenosquamous Carcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Mixed Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Metastatic Endometrioid Adenocarcinoma
• Recurrent Malignant Uterine Corpus Neoplasm
• Stage IV Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IVA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Stage IVB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
• Uterine Corpus Carcinosarcoma

Interventions

Type	Name	Description
DRUG	Cabozantinib S-malate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2013-05-08
• Primary completion: 2019-09-12
• Completion: 2024-10-24
• First posted: 2013-09-05
• Last updated: 2025-10-01
• Results posted: 2020-07-14

Locations

19 sites across 2 countries: United States, Canada